Failed Back Surgery Syndrome, Low Back Pain, Pain, Postoperative
Conditions
Brief summary
The purpose of this study is to find out the effectiveness of integrative medicine model for pain relief and improvement of function and quality of life on the patients with pain after back surgery.
Interventions
DEVICEelectroacupuncture and usual care
Electroacupuncture: Using 0.25 mm (diameter) X 0.40 mm (length) sized disposable stainless steel needles, electric stimulation will be applied with an electronic stimulator (ES-160, ITO co. LTD, Japan) 2 times/week × 4 weeks. Stimulation will be applied with the current in biphasic wave form. Acupuncture points are Jia-ji (Ex-B2, L3-L5; bilateral) as necessary points and reasonable points (according to decision of practitioner) as accessory points. Each session lasts 15 minutes. Usual care: Physical therapy and patient education will be performed 2 times per week for 4 weeks. ICT lasts 15 minutes and Hot or Ice pack lasts 10minutes. Doctors will educate patient physiology, pathology, and epidemiology of low back pain. And also suitable postures and exercises for low back pain will be educated.
DEVICEUsual care
Usual care: Physical therapy and patient education will be performed 2 times per week for 4 weeks. ICT lasts 15 minutes and Hot or Ice pack lasts 10minutes. Doctors will educate patient physiology, pathology, and epidemiology of low back pain. And also suitable postures and exercises for low back pain will be educated.
Sponsors
Korean Medicine Hospital of Pusan National University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
19 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Patients whose low back pain persisted or recurred after back surgery with or without leg pain. * Patients whose pain has been persisted at least 3 weeks recently and who are necessary to care intermittent medical treatments (eg. medication, injection, physio therapy). * Patients with pain, defined as an Visual Analogue Scale (VAS) value ≥ 50mm. * Patients who are 19 - 70 years of age. * Patients who agreed to voluntarily participate in this study and signed informed consent.
Exclusion criteria
* Patients who have been diagnosed with a serious disease that can cause low back pain (e.g., cancer, vertebral fracture, spinal infection, inflammatory spondylitis, cauda equine compression, or other disqualifying conditions). * Patients with progressive neurological deficit or severe neurological symptoms. * Patients whose pain causes are not resulted from spine or resulted from soft tissue diseases(e.g., cancer, fibromyalgia, rheumatoid arthritis, gout). * Patients with a chronic disease that could influences the effects of the treatment or the analysis of treatment results (e.g., cardiovascular disease, diabetic neuropathy, fibromyalgia, rheumatoid arthritis, dementia, epilepsy, or other disqualifying conditions). * Patients for whom acupuncture would be inappropriate or unsafe (e.g., hemorrhagic disease, clotting disorders, a history of receiving anticoagulant therapy, severe diabetes with a risk of infection, severe cardiovascular disease, or other disqualifying conditions) * Patients who are currently pregnant or planning the pregnancy. * Patients with psychiatric diseases. * Patients who are participating in other clinical trial. * Patients who are unable to sign informed consent. * Patients who are judged to be inappropriate for the clinical study by the researchers, such as inability to read and write Korean.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual Analogue Scale | up to 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Oswestry Disability Index | up to 4 months |
| EuroQoL 5-Dimension Questionnaire | up to 4 months |
Countries
South Korea
Outcome results
None listed